Generic Gemtesa Availability
Last updated on Apr 10, 2025.
Gemtesa is a brand name of vibegron, approved by the FDA in the following formulation(s):
GEMTESA (vibegron - tablet;oral)
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Manufacturer: UROVANT
Approval date: December 23, 2020
Strength(s): 75MG [RLD]
Is there a generic version of Gemtesa available?
No. There is currently no therapeutically equivalent version of Gemtesa available in the United States.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Gemtesa. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Use of vibegron to treat overactive bladder
Patent 12,102,638
Issued: October 1, 2024
Inventor(s): Piscitelli; Stephen C. et al.
Assignee(s): Urovant Sciences GmbH (Basel, CH)The present disclosure is directed to a method of treating overactive bladder comprising orally administering to a subject in need thereof an amount of from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron per day. The present disclosure is also directed to a pharmaceutical unit dosage composition comprising from about 60 mg to about 90 mg (e.g., about 75 mg) of vibegron for oral administration.
Patent expiration dates:
- March 22, 2040✓
- March 22, 2040
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Process for preparing beta 3 agonists and intermediates
Patent 12,180,219
Issued: December 31, 2024
Inventor(s): Xu; Feng et al.
Assignee(s): MERCK SHARP & DOHME LLC (Rahway, NJ)The application is directed to efficient and economical processes as described in more detail below for the preparation of the beta 3 agonists of the formula of I-7 and intermediate compounds that can be used for making these agonists. The present disclosure relates to a process for making beta-3 agonists and intermediates using ketoreductase (KRED) biocatalyst enzymes and methods of using the biocatalysts.
Patent expiration dates:
- March 12, 2034✓✓
- March 12, 2034
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Hydroxymethyl pyrrolidines as β3 adrenergic receptor agonists
Patent 8,247,415
Issued: August 21, 2012
Inventor(s): Berger Richard & Chang Lehua & Edmondson Scott D. & Goble Stephen D. & Ha Sookhee Nicole & Kar Nam Fung & Kopka Ihor E. & Li Bing & Morriello Gregori J. & Moyes Chris R. & Shen Dong-Ming & Wang Liping & Zhu Cheng
Assignee(s): Merck Sharp & Dohme Corp.The present invention provides compounds of Formula (I), pharmaceutical compositions thereof, and method of using the same in the treatment or prevention of diseases mediated by the activation of β3-adrenoceptor.
Patent expiration dates:
- December 1, 2030✓✓✓
- December 1, 2030
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Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists
Patent 8,653,260
Issued: February 18, 2014
Inventor(s): Berger Richard & Chang Lehua & Edmondson Scott D. & Goble Stephen D. & Ha Sookhee Nicole & Kar Nam Fung & Kopka Ihor E. & Li Bing & Morriello Gregori J. & Moyes Chris R. & Shen Ding-Ming & Wang Liping & Zhu Cheng
Assignee(s): Merck Sharp & Dohme Corp.The present invention provides compounds of Formula (I), pharmaceutical compositions thereof, and method of using the same in the treatment or prevention of diseases mediated by the activation of β3-adrenoceptor.
Patent expiration dates:
- April 2, 2029✓
- April 2, 2029
Related exclusivities
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Exclusivity expiration dates:
- December 23, 2025 - NEW CHEMICAL ENTITY
- December 18, 2027 - TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY INCONTINENCE, URGENCY, AND URINARY FREQUENCY IN ADULT MALES ON PHARMACOLOGICAL THERAPY FOR BENIGN PROSTATIC HYPERPLASIA (BPH)
More about Gemtesa (vibegron)
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- Drug class: urinary antispasmodics
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Glossary
| Term | Definition |
|---|---|
| Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
| Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
| RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
